Bioanalytical Science
Our Bioanalytical department has been supporting client’s project in the areas of method development validation, sample analysis, reporting and submission since the company's inception.
Our dedicated and knowledgeable scientists are well-trained in GLP and GCP regulations and have provided data of the highest quality to our clients.
The team uses state-of-the-art instruments, such as LC-MS/MS, UPLC, HPLC to complete projects with the highest data quality.
All procedures are as per principles of GLP and in compliance with applicable regulatory guidelines like USFDA, WHO, ANVISA, NPRA and EMA, and so on.
The team comprises of well-trained and experienced scientists in method development of simple to complex drugs and metabolites including endogenous substances, achiral and chiral assays.
In addition, MTRL has expertise in offering the services for the conduct of Invitro BA/BE biowaiver studies based on BCS classification system
- Method development and validation for a wide spectrum of drug substances.
- Quantitative analysis at picogram /mL concentration.
- Chiral Molecule Analysis.
- Complex bioanalysis of bound and total drug.
- Bioanalysis of conjugated and total drug (By enzymatic process).
- Hormones and Vitamin analysis.
- Invitro Dissolution study.
- Invitro permeability assay using Caco-2 Cell line (BCS-Bio waiver study).
- Bio Analytical methods for biosimilars including mAbs (Large molecule).
Infrastructure
| INSTRUMENTS SPECIFICATION | NO.OF INSTRUMENTS |
|---|---|
| LC-MS/MS ( Waters Xevo TQMS, Quattro Micro Mass, API 5500,4000& 3200) | 19 |
| ICPMS | 1 |
| GC-MS/HS | 1 |
| HPLC | 2 |
| DEEP FREEZERS (-200C) | 2 |
| DEEP FREEZERS (-300C) | 5 |
| DEEP FREEZER (- 400C) | 3 |
| DEEP FREEZERS (- 800C) | 9 |
Capabilities:
- Capacity to analyze 30,000 + samples / month.
- 230+ validated methods (incl. methods as low as 1pg /ml) and approx 6-8 new methods validated every month.
- Method development/validation for proprietary (NCE) and non-proprietary assays.
- Method transfer or cross validation between global sites, instruments, species & matrices.
- Methods for drug-drug interaction studies.
- Bioanalysis of drug and metabolites in a variety of biological matrices from preclinical and clinical trials.
- Ability to develop and validate highly sensitive assays in low pg/mL range.
- Ability to develop and validate methods well in advance based on patent expiry and business sense.
- Ability to accommodate projects with rapid turn-around-times.
- Qualified, trained & experienced team of bioanalytical professionals
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